OARTRAC SYSTEM
Dosimeter, Ionizing Radiation, Implanted
RADIADYNE
The following data is part of a premarket notification filed by Radiadyne with the FDA for Oartrac System.
Pre-market Notification Details
| Device ID | K141154 |
| 510k Number | K141154 |
| Device Name: | OARTRAC SYSTEM |
| Classification | Dosimeter, Ionizing Radiation, Implanted |
| Applicant | RADIADYNE 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman RADIADYNE 816 CONGRESS AVE. SUITE 1400 Austin, TX 78701 |
| Product Code | NZT |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-07-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851546007097 | K141154 | 000 |
| 00851546007080 | K141154 | 000 |
| 20851546007060 | K141154 | 000 |
Trademark Results [OARTRAC SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OARTRAC SYSTEM 85058933 not registered Dead/Abandoned |
Radiadyne, LLC 2010-06-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.